Paget Disease of Bone
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Sign up freeTop drugs studied for this disease
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FDA approval · 2020-04-29FDA Approved: RECLAST — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for RECLAST (zoledronic acid) filed by Sandoz Inc.
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FDA approval · 2020-02-21FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Dr. Reddy's Laboratories Limited)
The FDA approved a supplemental application for Zoledronic acid from Dr. Reddy's Laboratories Limited, authorizing a generic product through…
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FDA approval · 2019-08-19FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for alendronate sodium by Hikma Pharmaceuticals USA Inc.
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FDA approval · 2019-07-09FDA Approved: RISEDRONATE SODIUM — Original Application (Sun Pharmaceutical Industires Inc.)
FDA approved Sun Pharmaceutical's risendronate sodium as an original application for a generic product, with indications for osteoporosis-re…
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FDA approval · 2019-02-15FDA Approved: RISEDRONATE SODIUM — Original Application (Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd)
FDA approved the generic drug risedronate sodium under an Original Application, expanding access to this bisphosphonate for osteoporosis- an…
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FDA approval · 2018-06-29FDA Approved: ZOLEDRONIC ACID — Original Application (Gland Pharma Limited)
The FDA approved an Original Application for a generic zoledronic acid product by Gland Pharma Limited.
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FDA approval · 2017-07-07FDA Approved: RECLAST — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for RECLAST (zoledronic acid) submitted by Sandoz Inc.
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FDA approval · 2017-04-18FDA Approved: ALENDRONATE — Supplemental Application (Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.)
FDA approved a supplemental application for alendronate sodium tablets from Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.
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FDA approval · 2016-11-29FDA Approved: RISEDRONATE SODIUM — Original Application (Macleods Pharmaceuticals Limited)
FDA approved Macleods Pharmaceuticals Limited's original ANDA for a generic rise-dronate sodium product (RISEDRONATE SODIUM). The approved i…
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FDA approval · 2016-10-21FDA Approved: RISEDRONATE SODIUM — Original Application (Aurobindo Pharma Limited)
The FDA approved Aurobindo Pharma Limited's original ANDA for risedronate sodium, a generic osteoporosis treatment, enabling market entry.
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FDA approval · 2016-07-14FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
The FDA approved a supplemental application for a generic zoledronic acid product from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals)…
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FDA approval · 2016-05-24FDA Approved: RECLAST — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for RECLAST (zoledronic acid) submitted by Sandoz Inc. The approval updates the product's labeli…
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FDA approval · 2016-04-08FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for alendronate sodium filed by Aurobindo Pharma Limited (ANDA 090124).
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FDA approval · 2016-03-29FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
The FDA approved a supplemental application for alendronate sodium from Amneal Pharmaceuticals of New York LLC. This action indicates regula…
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FDA approval · 2016-03-25FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Sagent Pharmaceuticals)
FDA approved a supplemental application for zoledronic acid filed by Sagent Pharmaceuticals.
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FDA approval · 2016-03-22FDA Approved: BINOSTO — Supplemental Application (Radius Health, Inc.)
The FDA approved a supplemental application for Binosto (alendronate sodium) from Radius Health, Inc., updating the product labeling as part…
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FDA approval · 2016-02-12FDA Approved: ALENDRONATE SODIUM — Supplemental Application (EXELAN PHARMACEUTICALS INC.)
FDA approved a supplemental application for alendronate sodium from Exelan Pharmaceuticals Inc. under the ANDA program.
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FDA approval · 2015-12-15FDA Approved: RISEDRONATE SODIUM — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for risendronate sodium submitted by Apotex Corp., resulting in an approved change to the marketed p…
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FDA approval · 2015-12-09FDA Approved: RISEDRONATE SODIUM — Original Application (Macleods Pharmaceuticals Limited)
FDA approved the original application for risendronate sodium (generic risendronate) from Macleods Pharmaceuticals Limited.
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FDA approval · 2015-11-30FDA Approved: FOSAMAX — Supplemental Application (Organon LLC)
FDA approved a supplemental application for FOSAMAX (alendronate sodium) from Organon LLC.
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FDA approval · 2015-11-30FDA Approved: RISEDRONATE SODIUM — Original Application (Apotex Corp.)
FDA approved Apotex Corp.'s original ANDA for generic risedronate sodium (RISEDRONATE SODIUM), authorizing its marketing in the United State…
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FDA approval · 2015-11-30FDA Approved: RISEDRONATE SODIUM — Original Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved Sun Pharmaceutical Industries' risendronate sodium generic product under an Original Application (ANDA). Risendronate sodiu…
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FDA approval · 2015-10-31FDA Approved: CALCITONIN SALMON — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for Calcitonin Salmon submitted by Endo USA, Inc.
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FDA approval · 2015-10-19FDA Approved: ZOLEDRONIC ACID — Supplemental Application (BPI Labs LLC)
FDA approves a supplemental application for zoledronic acid from BPI Labs LLC under ANDA 202930. This action supports continued availability…
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FDA approval · 2015-09-23FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for alendronate sodium by Hikma Pharmaceuticals USA Inc., adding regulatory approval status for this…